Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/101695/2006.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 November 2007

Replaces: EMEA/CPMP/3097/02 (adopted by TGA 12 May 2005)

Categories: Multidisciplinary | Biosimilars | Other guidelines relevant for biosimilars

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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